Communication skills training for healthcare professionals working with people who have cancer (Review)

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1 Communication skills training for healthcare professionals working with people who have cancer (Review) Moore PM, Rivera Mercado S, Grez Artigues M, Lawrie TA This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2013, Issue 3

2 T A B L E O F C O N T E N T S HEADER ABSTRACT PLAIN LANGUAGE SUMMARY SUMMARY OF FINDINGS FOR THE MAIN COMPARISON BACKGROUND OBJECTIVES METHODS Figure RESULTS Figure Figure DISCUSSION AUTHORS CONCLUSIONS ACKNOWLEDGEMENTS REFERENCES CHARACTERISTICS OF STUDIES DATA AND ANALYSES Analysis 1.1. Comparison 1 CST vs no CST: HCP communication skills, Outcome 1 Used open questions Analysis 1.2. Comparison 1 CST vs no CST: HCP communication skills, Outcome 2 Clarified and/or summarised.. 58 Analysis 1.3. Comparison 1 CST vs no CST: HCP communication skills, Outcome 3 Elicited concerns Analysis 1.4. Comparison 1 CST vs no CST: HCP communication skills, Outcome 4 Showed empathy Analysis 1.5. Comparison 1 CST vs no CST: HCP communication skills, Outcome 5 Gave appropriate information. 61 Analysis 1.6. Comparison 1 CST vs no CST: HCP communication skills, Outcome 6 Gave facts only Analysis 1.7. Comparison 1 CST vs no CST: HCP communication skills, Outcome 7 Negotiation Analysis 2.1. Comparison 2 CST vs no CST: HCP communication skills: doctors only, Outcome 1 Used open questions. 64 Analysis 2.2. Comparison 2 CST vs no CST: HCP communication skills: doctors only, Outcome 2 Clarified and/or summarised Analysis 2.3. Comparison 2 CST vs no CST: HCP communication skills: doctors only, Outcome 3 Elicited concerns. 66 Analysis 2.4. Comparison 2 CST vs no CST: HCP communication skills: doctors only, Outcome 4 Showed empathy. 67 Analysis 2.5. Comparison 2 CST vs no CST: HCP communication skills: doctors only, Outcome 5 Gave appropriate information Analysis 2.6. Comparison 2 CST vs no CST: HCP communication skills: doctors only, Outcome 6 Gave facts only.. 69 Analysis 3.1. Comparison 3 CST vs no CST: HCP communication skills: nurses only, Outcome 1 Used open questions. 70 Analysis 3.2. Comparison 3 CST vs no CST: HCP communication skills: nurses only, Outcome 2 Clarified and/or summarised Analysis 3.3. Comparison 3 CST vs no CST: HCP communication skills: nurses only, Outcome 3 Elicited concerns. 71 Analysis 3.4. Comparison 3 CST vs no CST: HCP communication skills: nurses only, Outcome 4 Showed empathy. 72 Analysis 3.5. Comparison 3 CST vs no CST: HCP communication skills: nurses only, Outcome 5 Gave appropriate information Analysis 3.6. Comparison 3 CST vs no CST: HCP communication skills: nurses only, Outcome 6 Gave facts only.. 74 Analysis 4.1. Comparison 4 CST vs no CST: subgrouped by HCP type, Outcome 1 Used open questions Analysis 4.2. Comparison 4 CST vs no CST: subgrouped by HCP type, Outcome 2 Clarified and/or summarised.. 76 Analysis 4.3. Comparison 4 CST vs no CST: subgrouped by HCP type, Outcome 3 Elicited concerns Analysis 4.4. Comparison 4 CST vs no CST: subgrouped by HCP type, Outcome 4 Showed empathy Analysis 4.5. Comparison 4 CST vs no CST: subgrouped by HCP type, Outcome 5 Gave appropriate information.. 79 Analysis 4.6. Comparison 4 CST vs no CST: subgrouped by HCP type, Outcome 6 Gave facts only Analysis 5.1. Comparison 5 CST vs no CST: Other HCP outcomes, Outcome 1 Emotional exhaustion: Maslach Burnout Inventory: Analysis 5.2. Comparison 5 CST vs no CST: Other HCP outcomes, Outcome 2 Personal accomplishment: Maslach Burnout Inventory Analysis 6.1. Comparison 6 CST vs no CST: Patient outcomes, Outcome 1 Patient psychiatric morbidity (GHQ 12). 82 i

3 Analysis 6.2. Comparison 6 CST vs no CST: Patient outcomes, Outcome 2 Patient anxiety: Spielberger s State Trait Anxiety Inventory Analysis 6.3. Comparison 6 CST vs no CST: Patient outcomes, Outcome 3 Patient perception of HCPs communication skills Analysis 6.4. Comparison 6 CST vs no CST: Patient outcomes, Outcome 4 Patient satisfaction with communication. 84 Analysis 7.1. Comparison 7 Follow-up CST vs no follow-up CST: HCP communication skills, Outcome 1 Used open questions Analysis 7.2. Comparison 7 Follow-up CST vs no follow-up CST: HCP communication skills, Outcome 2 Clarified and/or summarised Analysis 7.3. Comparison 7 Follow-up CST vs no follow-up CST: HCP communication skills, Outcome 3 Elicited concerns Analysis 7.4. Comparison 7 Follow-up CST vs no follow-up CST: HCP communication skills, Outcome 4 Showed empathy Analysis 7.5. Comparison 7 Follow-up CST vs no follow-up CST: HCP communication skills, Outcome 5 Gave appropriate information Analysis 7.6. Comparison 7 Follow-up CST vs no follow-up CST: HCP communication skills, Outcome 6 Gave facts only Analysis 7.7. Comparison 7 Follow-up CST vs no follow-up CST: HCP communication skills, Outcome 7 Negotiation. 89 ADDITIONAL TABLES APPENDICES WHAT S NEW HISTORY CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST SOURCES OF SUPPORT DIFFERENCES BETWEEN PROTOCOL AND REVIEW INDEX TERMS ii

4 [Intervention Review] Communication skills training for healthcare professionals working with people who have cancer Philippa M Moore 1, Solange Rivera Mercado 1, Mónica Grez Artigues 1, Theresa A Lawrie 2 1 Family Medicine, P. Universidad Catolica de Chile, Santiago, Chile. 2 The Cochrane Gynaecological Cancer Group, Royal United Hospital, Bath, UK Contact address: Philippa M Moore, Family Medicine, P. Universidad Catolica de Chile, Lira 44, Santiago, Chile. moore.philippa@gmail.com. Editorial group: Cochrane Gynaecological Cancer Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 3, Review content assessed as up-to-date: 19 February Citation: Moore PM, Rivera Mercado S, Grez Artigues M, Lawrie TA. Communication skills training for healthcare professionals working with people who have cancer. Cochrane Database of Systematic Reviews 2013, Issue 3. Art. No.: CD DOI: / CD pub3. Background A B S T R A C T This is an updated version of a review that was originally published in the Cochrane Database of Systematic Reviews in 2004, Issue 2. People with cancer, their families and carers have a high prevalence of psychological stress which may be minimised by effective communication and support from their attending healthcare professionals (HCPs). Research suggests communication skills do not reliably improve with experience, therefore, considerable effort is dedicated to courses that may improve communication skills for HCPs involved in cancer care. A variety of communication skills training (CST) courses have been proposed and are in practice. We conducted this review to determine whether CST works and which types of CST, if any, are the most effective. Objectives To assess whether CST is effective in improving the communication skills of HCPs involved in cancer care, and in improving patient health status and satisfaction. Search methods We searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL) Issue 2, 2012, MED- LINE, EMBASE, PsycInfo and CINAHL to February The original search was conducted in November In addition, we handsearched the reference lists of relevant articles and relevant conference proceedings for additional studies. Selection criteria The original review was a narrative review that included randomised controlled trials (RCTs) and controlled before-and-after studies. In this updated version, we limited our criteria to RCTs evaluating CST compared with no CST or other CST in HCPs working in cancer care. Primary outcomes were changes in HCP communication skills measured in interactions with real and/or simulated patients with cancer, using objective scales. We excluded studies whose focus was communication skills in encounters related to informed consent for research. Data collection and analysis Two review authors independently assessed trials and extracted data to a pre-designed data collection form. We pooled data using the random-effects model and, for continuous data, we used standardised mean differences (SMDs). 1

5 Main results We included 15 RCTs (42 records), conducted mainly in outpatient settings. Eleven studies compared CST with no CST intervention, three studies compared the effect of a follow-up CST intervention after initial CST training, and one study compared two types of CST. The types of CST courses evaluated in these trials were diverse. Study participants included oncologists (six studies), residents (one study) other doctors (one study), nurses (six studies) and a mixed team of HCPs (one study). Overall, 1147 HCPs participated (536 doctors, 522 nurses and 80 mixed HCPs). Ten studies contributed data to the meta-analyses. HCPs in the CST group were statistically significantly more likely to use open questions in the post-intervention interviews than the control group (five studies, 679 participant interviews; P = 0.04, I² = 65%) and more likely to show empathy towards patients (six studies, 727 participant interviews; P = 0.004, I² = 0%); we considered this evidence to be of moderate and high quality, respectively. Doctors and nurses did not perform statistically significantly differently for any HCP outcomes.there were no statistically significant differences in the other HCP communication skills except for the subgroup of participant interviews with simulated patients, where the intervention group was significantly less likely to present facts only compared with the control group (four studies, 344 participant interviews; P = 0.01, I² = 70%). There were no significant differences between the groups with regard to outcomes assessing HCP burnout, patient satisfaction or patient perception of the HCPs communication skills. Patients in the control group experienced a greater reduction in mean anxiety scores in a meta-analyses of two studies (169 participant interviews; P = 0.02; I² = 8%); we considered this evidence to be of a very low quality. Authors conclusions Various CST courses appear to be effective in improving some types of HCP communication skills related to information gathering and supportive skills. We were unable to determine whether the effects of CST are sustained over time, whether consolidation sessions are necessary, and which types of CST programs are most likely to work. We found no evidence to support a beneficial effect of CST on HCP burnout, patients mental or physical health, and patient satisfaction. P L A I N L A N G U A G E S U M M A R Y Are courses aimed at improving the way doctors and nurses communicate with patients with cancer helpful? People with cancer, and those who care for them, often suffer from psychological stress which may be reduced by effective communication and support from their attending doctor, nurse or other healthcare professional (HCP). Research suggests communication skills do not reliably improve with experience, therefore, considerable effort is dedicated to courses to improve communication skills for HCPs involved in cancer care. Many different types of communication skills training (CST) courses have been proposed and are in practice. We conducted this review to determine whether CST works and which types of CST, if any, are the most effective. We found 15 studies to include in this review. All of these studies except one were conducted in nurses and doctors. To measure the impact of CST, some studies used encounters with real patients and some used role-players (simulated patients). We found that CST significantly improved some of the communication skills used by healthcare workers, including using open questions in the interview to gather information and showing empathy as a way of supporting their patients. Other communication skills evaluated showed no significant differences between the HCPs who received the training and those who did not. We did not find evidence to suggest any benefits of CST to patients mental and physical health, patient satisfaction levels or quality of life, however, few studies addressed these outcomes. Furthermore, it is not clear whether the improvement in HCP communication skills is sustained over time and which types of CST are best. 2

6 S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation] Communication skills training compared with no communication skills training for improving healthcare professionals (HCP) communication with cancer patients Patient or population: healthcare professionals working with patients with cancer Settings: outpatient or primary care Intervention: A communications skills training program Comparison: No communication skill training Outcomes Relative effect:(p value) No of participant interviews (studies) Quality of the evidence (GRADE) Comments HCP showed empathy Favoured the intervention (P=0.004) 727 (6 studies) high These data were consistent and did not display statistical heterogeneity(i²=0%) HCP used open questions Favoured the intervention (P=0.04) 679 (5 studies) moderate We downgraded the qualityoftheevidencedueto the statistical heterogeneity of the studies (I² = 65%) HCP gave facts only (simulated patients only) Favoured the control group (P=0.01) 406 (4 studies) moderate We downgraded the quality of this evidence due to the clinical and statistical heterogeneity of the studies (I² = 70%).This effect was not evident in the subgroup of real patients. Tests for subgroup differences were statistically significant Patient satisfaction with communication Not significantly different P= (2 studies) low We downgraded the quality of the evidence due to clinical and statistical heterogeneity(i² = 74%) andthefactthatonlytwo studies contributed data Patient anxiety: State trait Anxiety Inventory Favoured the control group (P=0.02) 169 (2 studies) very low We downgraded the quality of the evidence due to the clinical heterogeneity of the studies and the fact that only two studies contributed data. In addition, one of these studies 3

7 reported baseline differences in anxiety between the two groups (significantly higher in the control group) and it was not clear from the report whether the results were adjusted for this difference GRADE Working Group grades of evidence: High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx B A C K G R O U N D This is an updated version of a review that was originally published in the Cochrane Database of Systematic Reviews in 2003, Issue 2. Good communication between health professionals and patients is essential for high quality health care. Effective communication benefits the well-being of patients and health professionals, influencing the rate of patient recovery, effective pain control, adherence to treatment regimens, and psychological functioning (Fallowfield 1990; Gattellari 2001; Stewart 1989; Stewart 1996; Vogel 2009). Cancer sufferers have a high prevalence of psychological stress and need emotional and social support. Hence, it is important that from the start there is adequate communication about the diagnosis, prognosis and treatment alternatives (Hack 2011). Furthermore, treatment of psychological stress may have a positive effect on quality of life (Girgis 2009). Conversely, ineffective communication can leave patients feeling anxious, uncertain and generally dissatisfied with their care (Hagerty 2005) and has been linked to a lack of compliance with recommended treatment regimens (Turnberg 1997). Avoiding disclosing cancer as the diagnosis has been linked to higher rates of depression and anxiety and lower use of coping skills (Donovan-Kicken 2011). Complaints about health professionals made by patients frequently focus, not on a lack of clinical competence per se, but rather on a perceived failure of communication and an inability to adequately convey a sense of care (Moore 2011; Lussier 2005). Communication issues are an important factor in litigation (Levinson 1997). Ineffective communication is also linked to increased stress, lack of job satisfaction and emotional burnout amongst healthcare professionals (Fallowfield 1995; Ramirez 1995). Self-awareness, reflection and learning about communication skills may have benefits for health professionals, and prevent burnout. Most patients with cancer prefer a patient-centred or collaborative approach (Dowsett 2000; Hubbard 2008; Tariman 2010); however, there is a minority who prefer a more task-centred approach. Furthermore, patient preferences regarding the communication of bad news have been found to be culturally dependent (Fujimori 2009).This makes it imperative that health professionals understand the needs of the individual patient (Dowsett 2000; Sepucha 2010). The type of relationship that occurs in reality can be very different from that preferred by patients and doctors (Tariman 2010; Taylor 2011) and the literature suggests that patients with cancer continue to have unmet communication needs (Hack 2005). Taylor 2011 reported that a majority of clinicians liked to include emotional issues during their interviews with patients with cancer, however, clinical interviews tend to be predominated by biomedical discussion with only a minimal time dedicated to psychosocial issues (Hack 2011; Vail 2011). The ability to communicate effectively is a pre-condition of qualification for most healthcare professionals (HCPs) (ACGME 2009; CanMEDS 2011; GMC 2009). As communication skills do not reliably improve with experience alone (Cantwell 1997), communication skills training (CST) is mandatory in many training programs, therefore, considerable effort and expense is being dedicated to CST. 4

8 Description of the intervention CST courses/workshops generally focus on communication between HCPs and patients during the formal assessment procedure (interview), and include emphasis on skills for building a relationship, providing structure to the interview, initiating the session, gathering information, explaining, planning and closure (Silverman 2005). Building a relationship may be particularly relevant with patients with cancer where promoting a greater disclosure of individual concerns and feelings may enable optimum care. Breaking bad news and shared decision-making have been other focuses of CST for HCPs involved in cancer care (Fallowfield 2004; Paul 2009). Most approaches to teaching communication in health care incorporate cognitive, affective and behavioural components, with the general aim of promoting greater self-awareness in the HCP. CST based on acquiring skills may be more effective than programmes based on attitudes or specific tasks (Kurtz 2005) and is considered to be more effective if experiential. The essential components that facilitate learning have been highlighted in guidelines (Gysels 2004; Stiefel 2010) and include the following. Systematic delineation and definition of the essential skills (verbal, non-verbal and paralinguistic). Skills that are effective in communication with patients with cancer are defined (e.g. the use of open questions, incorporating a psychosocial assessment, demonstrating empathy). Pitfalls include leading questions, focusing only on the physical and failing to explore the more psychological issues and premature reassurance. However, some claim that the evidence base for this definition of essential skills is still weak (Cegala 2002; Paul 2009). Observation of learners: through the use of learning techniques such as role-play, participants are then given the opportunity to practice their communication skills using facilitating behaviours and avoiding blocking behaviours in a safe environment. Often, role-playing is aided by the use of simulated patients trained to represent someone with cancer, and who can provide a range of cues and responses to communication in the role-play, thus providing a safe opportunity for healthcare professionals to practice communication skills without distressing patients (Aspegren 1999; Kruijver 2001; Nestel 2007). Well-intentioned, descriptive feedback, which may be verbal or written. Video or audio-recordings and review permitting selfreflection. Repeated practice. Active small group or one-to-one learner-centred learning. Facilitators with training and experience (Bylund 2009). CST has been delivered in a variety of ways, for example, via sessions integrated into degree or diploma studies (e.g. Wilkinson 1999) or three to five day workshops using actors as simulated patients (Fallowfield 1990; Heaven 1996; Razavi 2000). The optimal length for CST is under debate. Gysels 2004 argues that longer courses are more effective. There is a wide variety of models and approaches to trials of communication skills training and interpreting the data is often hampered by poor methodological quality (Fallowfield 2004). The original 2004 version of this Cochrane review concluded, based on three randomised controlled trials, that there was some evidence that courses on CST for HCPs working with patients with cancer may be effective in improving HCP communication skills (Fellowes 2003). Since then, other reviewers have reached the same conclusions in different ways (Barth 2011; Bylund 2010; Kissane 2012). Whilst some have suggested that these positive effects can be maintained over time, others have concluded that a strong evidence base for a significant effect on trial outcomes is lacking (Alvarez 2006), particularly for an effect on patient outcomes (Uitterhoeve 2010). Why it is important to do this review There has been much research in this area since the original Cochrane review was published, including the conduct of several randomised controlled trials (RCTs), which were scant at the time of the original review. Other more recent reviews in the field have included a variety of studies with different study designs, however, none have conducted meta-analyses of the results from RCTs. By undertaking this systematic review and keeping it up-to-date we aimed to critically evaluate all RCTs that have investigated the effectiveness of CST for HCPs working in cancer care, in order to enable evidence-based teaching and practice in this important and expanding area. Furthermore, we hoped that a review and metaanalysis of data from such RCTs would provide stronger evidence of any potential benefits that CST may have on HCP behaviour and provide guidance on the optimal methodology and length of training, as well as how to ensure that these newly acquired skills are transferred to the work-place. O B J E C T I V E S To assess whether communication skills training is effective in changing behaviour of HCPs working in cancer care and in improving patient health status and satisfaction. M E T H O D S Criteria for considering studies for this review Types of studies 5

9 Randomised controlled trials (RCTs), including cluster-randomised studies. Types of participants Types of healthcare professionals (HCPs): All qualified HCPs (medical, nursing and allied health professionals) within all hospital, hospice and ambulatory care settings, working in cancer care. If a study included other non-professionals, the percentage of professionals in the sample was > 60%. If a study also included HCPs working in non-cancer care, the percentage of HCP working in cancer care was > 60%. Training of intermediaries (e.g. interpreters, advocates, self-help groups) was not considered. Types of patients: Men and women with a diagnosis of cancer, at any stage of treatment. If a study included patients with other diagnoses, patients with cancer made up > 60% of the study sample. We included studies that assessed interviews in both real and simulated patients (for definition see Appendix 1). Types of encounters: Consultations and interviews where cancer patient care is the main aim. We excluded trials that studied encounters where the aim was to improve the quality of informed consent or to disclose information for informed patient consent to participate in a RCT. Primary outcomes HCP communication skills Information gathering skills, such as open questions, leading questions, facilitation, clarifying and summarising Discovering the patients perspective such as eliciting concerns Explaining and planning skills such as giving the appropriate information, checking understanding, and negotiating procedures and future arrangements Supportive, building relationship skills such as empathy, responding to emotions/psychological utterances; and offering support Undesirable outcomes, including blocking behaviours such as interruptions and false reassurances, and providing facts only Secondary outcomes Other HCP outcomes Burnout Types of interventions We included only studies in which the intervention group had communication skills training (e.g. study days, teaching pack, distance learning, workshops; and including any mode of training such as audiotape feedback, videotape recording of interviews, role-play, group discussion, didactic teaching), and in which the control group received nothing beyond the usual, or received an alternative training to the intervention group. We included all types and approaches to teaching, any length of training and any focus of communication between professionals and patients with cancer within the context of patient care. We excluded studies whose focus was communication skills in encounters related to informed consent for research. This specific type of CST is under discussion as the subject of a separate Cochrane review. Patient-rated outcomes Patient health status Anxiety level/psychological distress Quality of life Patient Perception Perception of HCP s communication skills: clarification, assessment of concerns, information, support, trust Satisfaction Outcomes of significant other Perception of significant other Perception of HCP s communication skills: clarification, assessment of concerns, information, support, trust Satisfaction Types of outcome measures We included outcomes that measured changes in HCP behaviour or skills, other HCP outcomes and patient-related outcomes at any time after the intervention. We anticipated that many of these outcomes would be measured by validated study-specific observational rating scales and potentially subject to a high degree of intertrial methodological heterogeneity. Studies that only reported outcomes of changes in attitudes/knowledge on the part of the HCPs or patients without examining resulting changes in behaviour of HCPs were excluded from the review, as self-perceived improvements have been shown to be over-optimistic (Chant 2002). Search methods for identification of studies Electronic searches For the original review, the following databases were searched. CENTRAL (The Cochrane Library, 2001, Issue 3) MEDLINE (1966 to November 2001) EMBASE (1980 to November 2001) PsycInfo (1887 to November 2001) CINAHL (1982 to November 2001) 6

10 AMED (1985 to October 2001) SIGLE (Start to March 2002) (Grey literature database held by British Library) Dissertation Abstracts International (1861 to March 2002) Evidence-Based Medical Reviews (1991 to March/April 2001) For the updated review, the search strategy was modified by Jane Hayes (JH) of the Cochrane Gynaecological Cancer Review group (CGCRG), who extended the searches of CENTRAL, MED- LINE, EMBASE, PsycInfo and CINAHL to Febuary In addition, JH searched the Database of Reviews of Effects (DARE) in The Cochrane Library in September No language restrictions were applied. (See Appendix 2, Appendix 3, Appendix 4 for search strategies). Searching other resources We handsearched the reference lists of relevant studies that we identified from the electronic searches and the conference abstracts of the annual International Psycho-Oncology Society meetings. Data collection and analysis Selection of studies For the original review, two of three review authors, Deborah Fellowes (DF), Susie Wilkinson (SW) and Philippa Moore (PM) independently applied inclusion criteria to each identified study. For the update, PM and Solange Rivera Mercado (SRM) or Monica Grez Artigues(MGA) independently evaluated identified studies for inclusion. Disagreements were resolved by discussion between all three review authors. We identified potentially eligible studies from the search abstracts and retrieved the full text of the articles if the review criteria were met, or if the abstract contained insufficient information to assess the review criteria. Data extraction and management For the original data extraction, two review authors recorded the methodology (including study design, participants, sample size, intervention, length of follow-up and outcomes), quality and results of the included studies on a standardised data extraction form. For the updated review, we designed a new data extraction form to include some specific outcomes and a Risk of bias assessment. Two review authors extracted data independently (PM and SRM or MGA) and resolved any disagreement by discussion. We entered the data into Review Manager software (RevMan 2011) and checked for accuracy. Assessment of risk of bias in included studies The quality of eligible studies was assessed independently by three review authors (DF, SW, PM) for the original review, and by two review authors (PM, SRM) for the updated review. For included studies, we assessed the risk of bias as follows. 1. Selection bias: random sequence generation and allocation concealment. 2. Detection bias: blinding of outcome assessment. 3. Attrition bias: incomplete outcome data. 4. Reporting bias: selective reporting of outcomes. 5. Other possible sources of bias. For further details see Appendix 5. Results are summarised in a Risk of bias graph (Figure 1) and a Risk of bias summary. Figure 1. Risk of bias graph: review authors judgements about each risk of bias item presented as percentages across all included studies. 7

11 Measures of treatment effect Tools for assessing communication were diverse and usually consisted of validated questionnaires and scales. Data for all outcomes were continuous. We had planned to measure the mean difference (MD) between treatment arms, however most trials measured the same outcome using different scales, and so we used the standardised mean difference (SMD) for all meta-analyses. Unit of analysis issues The units of analyses included the HCPs, their patients and significant others, and their encounters/conversations/interviews. Two review authors (PM and SRM or MG) reviewed unit of analysis issues according to Higgins 2011 and differences were resolved by discussion. These included reports where there were multiple observations for the same outcome, e.g. several interviews involving the same HCP for the same outcome at different time points. When there were multiple time points for observation, we considered the data from the time point closest to the end of intervention as the post-intervention measurement. This ranged from immediately post-intervention to three months post-intervention. We also analysed the longest follow-up measurement for each study which ranged from two to 12 months. Dealing with missing data For included studies we noted the level of attrition. Studies with greater than 20% attrition were considered at moderate to high risk of bias. For all outcomes, we attempted to carry out analyses on an intention-to-treat basis. We did not impute missing outcome data. If data were missing or only imputed data were reported, we attempted to contact trial authors to request the missing data. Assessment of heterogeneity We assessed the heterogeneity between studies by visual inspection of forest plots, by estimation of the percentage heterogeneity between trials (the I² statistic) (Higgins 2003), and by a formal statistical test of the significance of the heterogeneity (Deeks 2001). We considered a P value of less than 0.10 and an I² > 50% to represent substantial heterogeneity. Assessment of reporting biases We intended to examine funnel plots corresponding to meta-analysis of the primary outcome to assess the potential for small study effects such as publication bias if a sufficient number of studies were identified, however, there were fewer than 10 studies in all meta-analyses. Data synthesis We used the random-effects model with inverse variance weighting for all meta-analyses (DerSimonian 1986) and pooled the standardised mean differences (SMDs), presenting these results with the corresponding 95% confidence intervals (CIs). Subgroup analysis and investigation of heterogeneity To investigate heterogeneity, we carried out subgroup analyses of the primary outcomes according to staff group (e.g. doctors and nurses), patient type (e.g. real or simulated) and type of comparison (e.g. CST versus no-cst or CST with follow-up versus CST alone). We had intended to carry out subgroup analyses according to the type of CST e.g. didactic teaching, distance learning, roleplay workshops, however this was not possible due to the wide variety of interventions included. We will attempt subgroup analyses in future versions of this review. Sensitivity analysis We performed sensitivity analysis for the primary outcomes to investigate heterogeneity between studies. Three studies compared a CST intervention with no CST after giving preliminary CST to all HCP participants (intervention and control groups). Where any of these three studies contributed to meta-analyses, we performed sensitivity analyses by excluding these data and compared the results. R E S U L T S Description of studies See: Characteristics of included studies; Characteristics of excluded studies. Results of the search For the original review, we identified 51 potentially relevant articles, of which we included three studies (Fallowfield 2002; Razavi 1993; Razavi 2002) and excluded 48 studies (Figure 2). For the updated review, we retrieved a total of 5472 articles; 4948 were either duplicates or were excluded on title. Of the remainder, we 8

12 identified 119 records for classification. On retrieval of the full text of these records, we included 39 records (pertaining to 15 studies) and excluded 80 records (pertaining to 70 studies; see Figure 3). Figure 2. Study flow diagram of original searches (November 2001and November 2003) 9

13 Figure 3. Study flow diagram of updated searches to 28 February 2012.*Therefore, 15 studies and 42 records in total (updated search results plus original results) 10

14 Included studies Of the 42 records included (3+39) from all the searches to date, we identified 15 trials in total (nine of which had multiple publications, including the original three included studies). Fourteen trials were published in full and one (Fujimori 2011) was available as a conference abstract only. Ten studies (Butow 2008; Fujimori 2011; Gibon 2011; Goelz 2009; Kruijver 2001; Lienard 2010; Razavi 1993; Razavi 2002; van Weert 2011; Wilkinson 2008) investigated the effect of CST in the intervention group compared with a control group with no intervention. One study (Fallowfield 2002) compared two interventions in four comparative groups: CST or no training, and the provision of individual feedback or no feedback. Three studies assessed the effect of a follow-up intervention after initial training: six bi-monthly consolidation workshops of three hours in length (Razavi 2003), four half-day supervision sessions spread over four weeks (Heaven 2006) and CD-ROM (Tulsky 2011). One study compared different durations of CST (Stewart 2007). Overall, the communication skills of 1147 healthcare professional (HCP) participants were reported in these studies and 2105 patient encounters were analysed. Patients with cancer were from various cancer care settings (59% women; mean age 60 years) and the studies enrolled the following HCPs. Doctors (eight studies): Butow 2008 = 30 oncologists; Fallowfield 2002 = 160 oncologists; Fujimori 2011 = 30 oncologists; Goelz 2009 = 41 mainly haematology/oncology doctors; Lienard 2010 = 113 residents; Razavi 2003 = 63 physicians (62% oncologists); Stewart 2007 = 51 doctors (18 oncologists, 17 family physicians and 16 surgeons); Tulsky 2011 = 48 oncologists. Nurses (six studies): Heaven 2006 = 61 nurses; Kruijver 2001 = 53 nurses; van Weert 2011 = 48 nurses; Razavi 1993 = 72 nurses; Razavi 2002 = 116 nurses; Wilkinson 2008 = 172 nurses. Other HCPs: one trial studied the effect of CST on radiotherapy teams which included a mixed group of 80 doctors, nurses, physicists and secretaries (Gibon 2011). The majority of the trials were conducted in Europe, with the exception of Stewart 2007 (Canada), Butow 2008 (Australia); Fujimori 2011 (Japan) and Tulsky 2011 (USA). The average age of the HCP participants (13 studies) was 39 years and the number of HCPs in the studies ranged from 30 to 172 (mean, 75). Women comprised approximately 50% of participants in the trials involving doctors and approximately 90% of those involving nurses. Their experience working with patients with cancer ranged from < two years to 24 years. With regard to previous CST, one study reported that 47% of the participants had received > 50 hours of CST prior to the trial (Heaven 2006); two studies reported that participants had received no previous CST (Goelz 2009; Wilkinson 2008). Fujimori 2011 reported no data relating to participant characteristics and we were unsuccessful in contacting the authors for more details. Most studies were conducted in the hospital outpatient setting except for two studies that involved professionals working in the community (primary care and hospices) (Heaven 2006; Wilkinson 2008) and four that involved HCPs working in an inpatient setting (Kruijver 2001; Lienard 2010; Razavi 2002; van Weert 2011). Type of intervention The objective of most trials was to train the professionals in general communication skills (Fallowfield 2002; Fujimori 2011; Gibon 2011; Heaven 2006; Razavi 1993; Razavi 2002; Stewart 2007; van Weert 2011; Wilkinson 2008). Two trials aimed to train professionals specifically to detect and respond to patients emotions (Butow 2008;Tulsky 2011). Two trials trained HCPs in giving bad news (Lienard 2010; Razavi 2003) and Goelz 2009 trained HCPs in addressing the transition to palliative care. Kruijver 2001 concentrated on CST for nurses admission interviews. Most trials specified the use of learner-centred, experiential, adult education methods by experienced facilitators (10 trials: Butow 2008; Fallowfield 2002; Goelz 2009; Heaven 2006; Lienard 2010; Razavi 2003; Stewart 2007; Tulsky 2011; van Weert 2011; Wilkinson 2008). Co-teaching was stated in four studies (Goelz 2009; Heaven 2006; Kruijver 2001; Razavi 1993). CST was taught in small groups (range three to 15 participants) in 12 trials (Butow 2008; Fallowfield 2002; Goelz 2009; Heaven 2006; Kruijver 2001; Lienard 2010; Razavi 1993; Razavi 2002; Razavi 2003; Stewart 2007; van Weert 2011; Wilkinson 2008). All small-group studies used role-play, although it was often unclear if the cases used were pre-defined or true cases of the participants, and if the role-play was between participants or with simulated patients. In all studies, real patients were only used for the assessment interviews, and not during training. Most interventions included written material (10 trials; Butow 2008; Fallowfield 2002; Goelz 2009; Kruijver 2001; Razavi 1993; Razavi 2002; Razavi 2003; Stewart 2007; van Weert 2011; Wilkinson 2008) and short didactic lectures (eight trials; Butow 2008; Goelz 2009; Kruijver 2001; Lienard 2010; Razavi 1993; Razavi 2002; Razavi 2003; Wilkinson 2008). Six trials specified 11

15 the use of role-modelling (Butow 2008; Heaven 2006; Kruijver 2001; Stewart 2007; Tulsky 2011; Wilkinson 2008); and 10 trials specified the use of video material (Butow 2008; Goelz 2009; Fallowfield 2002; Heaven 2006; Kruijver 2001; Razavi 1993; Stewart 2007; Tulsky 2011; van Weert 2011;Wilkinson 2008). Two trials described e-learning: 1.5 hour video conferences as follow-up after the CST (Butow 2008) and use of a CD-ROM as follow-up after a communication skills lecture (Tulsky 2011). The type of learning in Fujimori 2011 was not specified. The participants received feedback from their tutors either verbally (Butow 2008; Goelz 2009; Heaven 2006; Kruijver 2001;Lienard 2010; Razavi 1993; Razavi 2002; Razavi 2003; Stewart 2007; Tulsky 2011; van Weert 2011;Wilkinson 2008) or in writing ( Fallowfield 2002). In addition, Butow 2008 described feedback from the simulated patients, and Goelz 2009 from the participants peers. No study stated whether the feedback was structured using a check-list. Duration of intervention One trial had very short on-site training with no follow-up: Stewart 2007 (six hours). Four trials included on-site training that lasted 24 hours or less with no follow-up intervention (two2 days: Fujimori 2011; 24 hours: Razavi 1993; 24 hours over three days:fallowfield 2002 and Wilkinson 2008). Seven trials included on-site training of less than 24 hours but with follow-up sessions, including: three-day course followed by four three-hour weekly sessions with one-to-one supervision (Heaven 2006); 1.5-day course followed by four 1.5-hour monthly video conferences (Butow 2008); one day course with a follow-up meeting at six weeks (van Weert 2011); 19-hour course followed by six three-hour consolidation workshops (Razavi 2003); 18-hour course with a follow-up meeting at two months (Kruijver 2001); 11-hour course followed by one-to-one coaching at 12 weeks (Goelz 2009); 1-hour lecture followed by the use of a CD-ROM for one month (Tulsky 2011). Three trials had longer on-site training: 38 hours (Gibon 2011), 40 hours (Lienard 2010) and 105 hours (Razavi 2002). Some on-site training was on consecutive days (Fallowfield 2002: three-day residential course; Wilkinson 2008: three days; Fujimori 2011: two days); other on-site training was spread over a longer period of time (Kruijver 2001; Lienard 2010; Razavi 1993; Razavi 2002; Razavi 2003), ranging from weekly for three weeks (Razavi 2003) to bimonthly over an eight-month period (Lienard 2010). Measurement of Outcomes Primary Outcomes Most studies measured outcomes before and after the CST (or no CST). Changes in HCP behaviour were measured in interviews involving simulated and/or real patients as follows. simulated patients only: five trials (Fujimori 2011; Gibon 2011; Goelz 2009; Razavi 1993; Stewart 2007); real patients only: four trials (Fallowfield 2002; Heaven 2006; Tulsky 2011; van Weert 2011); real and simulated patients: five trials (Butow 2008; Kruijver 2001; Lienard 2010; Razavi 2002; Razavi 2003). One trial measured HCP behaviour in interviews with simulated patients only when real patients were not available, however, the data were analysed together (Wilkinson 2008). It is not clear whether the patients in the study by Fujimori 2011 were simulated or real, or how many patient encounters were evaluated. Without counting Fujimori 2011, investigators reported on a total of 1,761 tapes of simulated patient encounters and 1,932 tapes of real patient encounters. The number of real patient interviews per HCP, assessed at each assessment point, ranged from one (Razavi 2002; Razavi 2003) to six (Kruijver 2001). Interviews were mostly assessed using audio recording (Gibon 2011; Heaven 2006; Lienard 2010; Razavi 2002; Razavi 2003; Stewart 2007; Tulsky 2011) or video recording (Butow 2008; Fallowfield 2002; Goelz 2009; Kruijver 2001; Razavi 1993; Razavi 2002; Razavi 2003; Wilkinson 2008). The Fujimori 2011 abstract does not describe how participants were assessed. HCP communication skills were evaluated using a variety of scales (see Table 1). Almost every trial used its own unique scale; only two scales were used in more than one study: the Cancer Research Campaign Workshop Evaluation Manual (CRCWEM) (Booth 1991) (Razavi 1993; Razavi 2002; Razavi 2003); and LaComm, a French Communication Analysis Software (LaComm; Gibon 2010) (Gibon 2011; Lienard 2010). Most studies mention that their scale had been validated. The scales had an average of 25 variables (range six to 84). Most studies used more than one rater, and the inter-rater reliability was considered acceptable by the authors and ranged from 0.49 to All the trials included measurement of outcomes relating to HCPs supportive/building relationship skills (Table 2). One study measured supportive skills only for HCPs outcomes (Tulsky 2011). Other frequently measured outcomes related to: information gathering e.g. open questions (10 studies: Butow 2008; Fallowfield 2002; Gibon 2011; Heaven 2006; Kruijver 2001; Lienard 2010; Razavi 1993; Razavi 2002; Razavi 2003; Wilkinson 2008); clarifying or summarising (seven studies: Fallowfield 2002; Gibon 2011; Goelz 2009; Kruijver 2001; Razavi 1993; Razavi 2002; Razavi 2003) and eliciting concerns (eight studies: Butow 2008; Goelz 2009; Heaven 2006; Kruijver 2001; Razavi 1993; Razavi 2002; Razavi 2003; Stewart 2007); explaining and planning e.g. appropriate information giving (nine studies: (Fallowfield 2002; Fujimori 2011; Goelz 12

16 2009; Lienard 2010; Razavi 2002; Razavi 2003; Stewart 2007; van Weert 2011: Wilkinson 2008) and negotiating (seven studies: Butow 2008; Gibon 2011; Heaven 2006; Lienard 2010; Razavi 1993; Razavi 2003; Stewart 2007). Secondary Outcomes Other HCP outcomes that were measured in these studies included: HCP health status (six trials: Butow 2008; Kruijver 2001; Lienard 2010; Razavi 1993; Razavi 2002; Razavi 2003); HCP perception of the interview (three trials: Fallowfield 2002; Razavi 2002; Razavi 2003); HCP perception of their behaviour change (eight trials: Fallowfield 2002; Fujimori 2011; Gibon 2011; Kruijver 2001; Razavi 2002; Razavi 2003; Tulsky 2011; Wilkinson 2008); HCP perception of their attitude change (eight trials: Butow 2008; Fallowfield 2002; Kruijver 2001; Lienard 2010; Razavi 1993; Razavi 2002; Razavi 2003; Wilkinson 2008). We considered HCP perceptions to be very subjective outcomes and so excluded these from our review. Patient outcomes were measured in 11 trials (Butow 2008; Fallowfield 2002; Fujimori 2011; Kruijver 2001; Lienard 2010; Razavi 2002; Razavi 2003; Stewart 2007; Tulsky 2011; van Weert 2011; Wilkinson 2008) including: patients perception of the interview (nine trials: Fallowfield 2002; Fujimori 2011; Kruijver 2001; Lienard 2010; Razavi 2002; Razavi 2003; Stewart 2007; Tulsky 2011; Wilkinson 2008); patient health status (seven trials: Butow 2008; Fujimori 2011; Kruijver 2001; Razavi 2003; Stewart 2007; Wilkinson 2008); objective measure of patients communication (five trials: Kruijver 2001; Lienard 2010; Razavi 2002; Razavi 2003; van Weert 2011). Two trials measured HCP communication with significant others (Goelz 2009; Razavi 2003); one trial measured the satisfaction of significant others (Razavi 2003). All secondary outcomes except the objective measurement of patient communication were measured with questionnaires, most of which were developed locally and it was not always stated whether they had been previously validated (see Table 3 and Table 4). The following validated questionnaires were used: HCP health status: Maslach Burnout Inventory (MBI) (used by Butow 2008; Kruijver 2001; Lienard 2010; Razavi 2003); patients perception of or satisfaction with the interview (used by Fallowfield 2002; Butow 2008; Razavi 2002; Razavi 2003; Stewart 2007; Wilkinson 2008); patient health status: General Health Questionnaire 12 or GHQ12 (used by Fallowfield 2002; Wilkinson 2008); European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 or QLQ- C30 (used by Butow 2008; Kruijver 2001); Hospital Anxiety and Depression Scale (HADS) (used by Butow 2008; Razavi 2002; Razavi 2003); Speilberger s State Trait Anxiety Inventory (STAI-S) (used by Razavi 2003; Wilkinson 2008). Timing of the measurement of outcomes Most studies measured communication skills prior to the intervention (within one to four weeks) and after a post-intervention period (between one week and six months). Two studies had a further measurement at 12 and 15 months post-intervention respectively (Butow 2008; Fallowfield 2002). Three studies evaluated the effects of follow-up CST interventions conducted between one and six months after the preliminary CST intervention (Heaven 2006; Razavi 2003; Tulsky 2011). Excluded studies We excluded 118 studies in total, 48 of which were excluded in the original review (November 2001 and November 2003 searches) (see Figure 2). From the updated search, we excluded 80 full text records (pertaining to 70 studies). Of the 118 studies excluded, 97 of these studies were either not RCTs, or were not intervention studies of communication skills training. We excluded the remaining 21 RCTs for the following reasons: CST for patients not HCPs (de Bie 2011; Clark 2009; Shields 2010; Street 2010; Smith 2010; Rosenbloom 2007); CST in HCPs who did not work specifically in cancer care (Brown 1999; Hainsworth 1996; Roter 1995; Szmuilowicz 2010; Wetzel 2011); intervention was not CST (Cort 2009); CST was aimed at facilitating recruitment of patients to trials (Wuensch 2011); CST was only measured in the intervention group not the control group (Fukui 2008); HCP behaviour change was not measured or was selfassessed (Bernard 2010; Brown 2012; Claxton 2011; Hundley 2008; Ke 2008; Pelayo 2011; Rask 2009). See Characteristics of excluded studies and Appendix 6. Risk of bias in included studies We considered studies to be at a low risk of overall bias if we assessed the individual risk of bias criteria as low risk in 3/6 criteria. As a result, we considered 12 of the 15 included RCTs to be at a low risk of overall bias (see Characteristics of included studies and Figure 1). 13